NCT03875131

Definition, Quantification, and Utility of Biomarkers of Repetitive Brain Injury in Predicting Concussion and Other Long-Term Injury Risks in Patients With Atrial Fibrillation (Concussion AF)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Intermountain Health Care, Inc. · Academic / Other
• Sex: All
• Age: 65 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective clinical study designed to evaluate biomarkers of brain injury and dementia incidence and moderate cognitive decline rates in moderate- to high-risk atrial fibrillation patients that undergo standard of care atrial fibrillation management.

Detailed description

A written informed consent will be obtained from atrial fibrillation patients seen at Intermountain Medical Center who meet the study eligibility criteria. Following the baseline visit for obtaining informed consent and conduct of baseline procedures, subjects will be required to return to clinic at 6, 12, 18 and 24 months after enrollment. Cognitive testing will be performed at baseline and repeated at 24 months. As much as possible, the study follow-up visits will be scheduled at the same time as the patients' regular visits for clinical care. Six questionnaires will be administered at the baseline visit and repeated at the 24-month visit. At the time of cognitive assessment, the following will be completed, if not already performed as part of usual standard of care: complete blood count, protime/INR, basic metabolic profile, review of cardiac medications, and review of adverse events and hospitalizations. Additional serum tests will be performed on all subjects at enrollment and at the 24-month visit. Biomarkers will be drawn at specific intervals (baseline, 6, 12, 18, and 24 months) then on an as needed basis (within 7 days) when treatments for atrial fibrillation that may increase brain injury risk occur.

Conditions

• Cognitive Change

Interventions

Type	Name	Description
OTHER	Biomarkers of Dementia and Cognitive Decline	Biomarkers will be obtained at baseline, 6, 12, 18, and 24 months. The six questionnaires listed below will be administered at the baseline visit, and repeated at the 24-month visit to evaluate cognitive decline. * Mini-Mental Status Evaluation * Hachinski Ischemic Scale * Cognitive Subscale of Alzheimer's Disease Assessment Scale * Disability Assessment for dementia * Quality of life improvement as assessed by: * Minnesota Living with Heart Failure Scale * Anti-Clot Treatment Scale (ACTS) Quality of Life Survey

Timeline

• Start date: 2017-07-15
• Primary completion: 2022-10-24
• Completion: 2022-10-24
• First posted: 2019-03-14
• Last updated: 2024-05-24

Locations

1 site across 1 country: United States